San Sebastian De Los Reyes

Researchers are conducting a prospective, multicenter observational study to create a registry for patients with unresectable locally advanced or metastatic breast cancer. This study includes patients diagnosed from January 2016 onwards, either at first diagnosis or after recurrence. Treatment choices are made independently by physicians, and the study does not specify any treatment regimen. The study groups are defined by breast cancer subtypes based on receptor expression, including Luminal A-like, Luminal B-like HER2 negative and positive, HER2-enriched, and Triple Negative subtypes. Since this is an observational study, patients receive standard care as determined by their doctors, and no intervention is assigned by the study. Participants medical records and disease management data will be collected and reviewed over an 8-year period. Researchers will evaluate the distribution of breast cancer subtypes, patient and tumor characteristics, hereditary risk factors, gender differences in disease progression, timing of primary tumor surgery, and biomarker presence in tumor and blood samples. Patients may withdraw consent at any time, and the study aims to follow patients until death or study completion.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 in people who have excess body weight and knee osteoarthritis. This study compares two doses of NNC0487-0111 given as weekly injections under the skin against a placebo, with the goal of helping participants lose weight and reduce knee pain. Participants have knee osteoarthritis confirmed by clinical and radiographic criteria and will follow a reduced-calorie diet and increased physical activity throughout the study. Participants will be randomly assigned to receive one of three treatments NNC0487-0111 dose level 1, NNC0487-0111 dose level 2, or a placebo, all given once weekly by subcutaneous injection using a pre-filled pen injector. The injections will be administered to the thigh, abdomen, or upper arm. All participants will be encouraged to follow a reduced-calorie diet and increase physical activity during the trial. The treatment period lasts for 80 weeks. Throughout the study, participants will have regular assessments of body weight, knee pain, physical function, and other health measures. Researchers will collect data on changes in weight, knee pain scores using the WOMAC index, physical function, blood pressure, cholesterol levels, blood sugar markers, and use of pain medication. Safety will be monitored through reporting of adverse events. The study is expected to continue until August 2028, with visits and evaluations occurring at scheduled intervals during the treatment period.

Researchers are conducting a three-part Phase 3 clinical trial to evaluate a potential new medicine called Sofetabart Mipitecan Sofe-M in people with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancers. The study focuses on patients with platinum-resistant cancer in Part A, meaning their disease worsened during or within six months of platinum-based chemotherapy, and platinum-sensitive cancer in Parts B and C, where disease remained controlled for more than six months after platinum treatment. The goal is to assess whether Sofe-M works better than current standard treatments and to understand its safety. Participants receive treatments administered intravenously. Part A compares Sofe-M to investigators choice of chemotherapy or Mirvetuximab Soravtansine MIRV. Parts B and C compare Sofe-M plus bevacizumab to platinum-based doublet chemotherapy plus bevacizumab. The study includes multiple chemotherapy options such as paclitaxel, topotecan, gemcitabine, and pegylated liposomal doxorubicin. Each participants involvement duration depends on their response to treatment. During the trial, participants undergo regular assessments including imaging to measure progression-free survival and overall survival. Researchers also track tumor marker responses, side effects, quality of life scores, and pharmacokinetics of Sofe-M. The study uses a randomized design without masking. Follow-up can last up to about 70 months, allowing for long-term safety and effectiveness monitoring.

Researchers are evaluating the safety and effects of NNC0487-0111 in adults with excess body weight and knee osteoarthritis. This study compares the active treatment with a placebo injection given once weekly. The goal is to assess weight loss and pain reduction over a long-term period, as well as other health measures related to osteoarthritis and metabolic health. Participants are randomly assigned to receive one of two dose levels of NNC0487-0111 or a placebo injection, both administered under the skin once a week. These injections are given alongside a reduced-calorie diet and increased physical activity. The treatment period lasts up to 80 weeks, during which participants follow the specified lifestyle changes. Throughout the study, participants will have regular assessments including body weight, knee pain and function scores WOMAC, physical functioning, blood pressure, cholesterol levels, blood sugar control HbA1c and fasting glucose, and use of pain medications. Safety events and adverse reactions are monitored up to week 84. Participants will be followed closely with these measurements to evaluate the treatments impact and overall safety.

Researchers are evaluating if a combination of Venetoclax, Azacytidine, and Quizartinib works better than the standard treatment of Venetoclax and Azacytidine to treat adult patients with newly diagnosed acute myeloid leukemia AML who cannot receive standard induction therapy due to age, other health issues, or risk factors. The study aims to determine which treatment offers a better chance of overall survival. Participants will be randomly assigned to one of two treatment groups. One group will receive Azacytidine by subcutaneous injection daily for seven days in each 28-day cycle, Venetoclax orally for seven days alongside Azacytidine, and Quizartinib orally from days 8 to 21, with doses adjusted based on genetic markers. The other group will receive Azacytidine injections for seven days and Venetoclax orally for seven days per cycle without Quizartinib. Treatments continue until disease progression, unacceptable side effects, or other criteria for stopping are met. During the study, participants will have regular visits for treatment and monitoring. Researchers will collect survival information and follow up by phone or clinic visits every three months for two years after the last patient enrolls. The main outcome measured is overall survival over four years. Additional outcomes include event-free survival and complete response rates over four years. Safety and health assessments will be regularly conducted throughout the trial.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

This research aims to evaluate the effectiveness, safety, and tolerability of zeleciment basivarsen DYNE-101 in treating participants with myotonic dystrophy type 1 DM1. The trial is a Phase 3 interventional study sponsored by Dyne Therapeutics and includes a comparison with a placebo. The study includes an independent committee that regularly reviews safety data to ensure participant well-being. Participants will be randomly assigned to receive either DYNE-101 or a matching placebo through intravenous infusion every 8 weeks during a 48-week placebo-controlled period. Following this, all participants will enter a 24-week long-term extension period where those initially on placebo will begin receiving DYNE-101, while those already on DYNE-101 will continue treatment on the same schedule. During the study, participants will undergo various assessments including physical performance tests like the 5 Times Sit-To-Stand and 10-Meter WalkRun Test, muscle strength measurements, clinician and patient global impressions, and health indexes specific to DM1. Blood samples will be collected to analyze drug concentration and antibody levels. The total participation spans up to approximately 80 weeks, including screening, treatment, and follow-up, with ongoing safety monitoring throughout.

Researchers are studying how inflammatory bowel disease IBD activity affects frailty in patients aged 60 years and older. This observational, multicenter, prospective, and longitudinal study aims to understand if frailty and related risks like hospitalization and mortality can be reversed with proactive treatment in frail patients with active IBD. The study also evaluates which frailty index best predicts complications in this population. At the start, four clinical frailty indices will be calculated for each participant, alongside recording clinical variables related to IBD and other health conditions. Patients will be followed through three visits at 3, 6, and 12 months, during which frailty, disease activity, treatment changes, adverse effects, hospitalizations, and mortality will be reassessed to track progress and outcomes. Participants will be involved in these visits where various assessments will be done, including measuring frailty and comorbidities and reviewing their IBD activity and treatments. The main outcomes include assessing the impact of IBD activity on frailty and how frailty affects hospitalization and mortality risk over a 12-month period. The study is led by the Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and runs until May 2027.

The trial investigates treatment options for adults with newly diagnosed multiple myeloma who are eligible for stem cell transplantation. It is a Phase III, open-label, randomized study comparing three treatment approaches to evaluate their effectiveness in achieving minimal residual disease negativity using next-generation flow cytometry. The study aims to compare an extended VRD regimen plus early rescue intervention with two Isatuximab-containing regimens. Participants are assigned to one of three groups Arm A receives Isatuximab combined with VRD followed by autologous stem cell transplant ASCT, then consolidation and continuous treatment with Lenalidomide and monthly Isatuximab Arm B receives an extended VRD regimen with ASCT plus early rescue intervention involving Isatuximab-Iberdomide-Dexamethasone, followed by consolidation and continuous treatment with adjusted VRD cycles Arm C is treated with Isatuximab, Iberdomide, VRD, and ASCT, followed by consolidation and continuous treatment with Iberdomide and monthly Isatuximab. Each treatment phase includes induction, ASCT, consolidation, and continuous therapy lasting approximately 24 months or longer. Throughout the study, participants undergo multiple cycles of treatment with frequent dosing schedules, including intravenous infusions and oral medications. Researchers assess the primary outcome by measuring the proportion of participants who are MRD-negative after 18 cycles plus ASCT, approximately 24 months. Safety and progression-free survival are monitored over about 78 months. The study also involves bone marrow analyses, adherence tracking, and reviews of therapeutic programs up to 36 months. Participants are followed closely for treatment response and adverse events during and after therapy.

Researchers are conducting an observational, epidemiological study to understand thrombosis in patients diagnosed with cancer. This study focuses on patients who experience venous or arterial thromboembolic events, either symptomatic or incidental, occurring within a month before cancer diagnosis or any time afterward. The study collects detailed information about the characteristics and timing of these events in relation to cancer diagnosis to better understand this condition. The study does not involve any interventions or treatments, as it is non-interventional and observational. Data is gathered from multiple centers, tracking details such as the location and vessel of origin of the thromboembolic event, tumor characteristics, and treatment administered for cancer at baseline. Patients are followed up for 12 months to assess their situation and outcomes related to thrombosis and cancer. Participants are involved through data collection at baseline and follow-up visits. Researchers assess imaging-confirmed thromboembolic events using techniques like Doppler echocardiography and CT angiography. The study measures various outcomes including event diagnosis, tumor stage, timing between cancer diagnosis and thrombosis, and patient status at one year. This registry provides valuable information about cancer-associated thrombosis over time.